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Wednesday, 31 July 2013 06:52

Bonus BioGroup Has Completed the Establishment of the First Facility Worldwide for Growing Human Bone Grafts

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Bonus BioGroup Has Completed the Establishment of the First Facility Worldwide for Growing Human Bone Grafts

The new and innovative facility will provide the company in its clinical trials, expected to commence in the second half of 2013.

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Bonus BioGroup announces today the completion of a first-of-its-kind facility for growing human bone grafts, with an approximate area of 750 square meters within a complex of new facilities in Matam Industrial Park in Haifa. 

The new production facility includes a set of Grade-B cleanrooms (of the standard required for producing live human bone grafts), as well as quality control and assurance labs, to ensure the compliance of the production process with Good Manufacturing Practice (GMP), required by regulators. Generally, the set of cleanroom required for producing human bone grafts is of a higher standard than that required for Medicines or Medical Devices (Grade C-D).

By establishing the first facility in the world for growing live human grafts, Bonus has achieved the independent production capacity of growing bone grafts of the quality and mass required for its clinical trials, scheduled to commence in the second half of the year (subject to regulatory approvals).

After three to four months from the transplant of human bone grafts in the patients participating in the first clinical trial, first significant interim results can be achieved.

The facility allows Bonus BioGroup full control over the entire bone graft growing process, independently of any collaboration or other parties. Moreover, the successful initiation of the facility stands as proof to Bonus BioGroup's ability to establish and operate a worldwide network of bone graft growing facilities.

After concluding the clinical trials and receiving the approval for marketing live human bone grafts, Bonus BioGroup will be able to use the production facility to supply grafts for commercial use, by producing tailored bone grafts, pre-designed to accommodate the patient's bone deficiency.

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